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Compelling Reasons For Doing Bio Equivalence Studies In India | 8272
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Compelling Reasons for Doing Bio Equivalence Studies in India

2nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

Mak Jawadekar

Special Issue BABE-2011: Posters: JBB

DOI: 10.4172/0975-0851.1000105

 Emerging markets are no more an option, but a strategic imperative for global clinical research  India is one of the fastest growing clinical research destination with a growth rate 2-1/2 times the overall market growth.  As the world?s third largest producer of drugs by volume, with drug research and development work force, india is a major player in the pharmaceutical industry.  India has over 100 fda approved manufacturing units. India has fi led the maximum number of andas in the us almost equivalent or more than the number of andas fi led by us companies.  Indias clinical research landscape is undergoing a glorious metamorphosis, aided by uniquely diff erentiating capabilities, a rapidly transforming health care market and an enabling environment i.e rapidly adopting itself to global standards.  India?s strength in formulation development, new drug delivery system and backed by excellent chemistry and bio analytical technics has brought down cost of bio equivalence studies dramatically and without compromising international standards  India is rated as one of the most attractive destinations for clinical trials and bio equivalence studies by various surveys.  India?s capability in bio equivalence has evolved with exceptionally good knowledge, highly trained and skilled technical man power in bio analytical services including method development validation and sample processing with strict adherence to cfr part xi.  Huge volunteer data base, experience & knowledgable ethics committee, new schedule y of the regulators enables compliance with global regulations.  I had an opportunity to audit one of the leading ba/be centres in india namely, quest life sciences  Th is centre is audited and approved by usfda having 100 beds clinical facility and a good bio analytical laboratory, has fi led over 30 andas in the us.  Th ey have a volunteer data base over 3000 subjects and in addition over 800 post menopausal women subjects.  Th e company has even conducted bio equivalence studies on cancer patients.  Th ese studies have been fi led in the us besides european regulatory requirements.  Th ey have faced innumerable audits from international clients, mainly from the us and europe.  I was surprised to fi nd that the cost of the ba/be studies in india is less than half of the study conducted in the us besides study schedules is one of the fastest as compared to many other centres outside india.  Quest has made a couple of para iv fi lings.  A slide show of one of the facilities is available on request